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Articles from April 2016

PM Planning / 483

PM Planning / 483

April 18, 2016

Preventative Maintenance (PM) should be based on a proactive process that looks at the overall health of a chamber.  A robust protocol will help anticipate problems and outages by recording the health of all components.  Execution of the PM protocol should be performed on a routine schedule that is...

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Chamber Cleaning / 483

Chamber Cleaning / 483

April 16, 2016

An overlooked part of the chamber maintenance is the cleaning of the chambers and is not being considered as a critical part of their operation.  This lack of attention can lead to 483’s being issued by auditors. Related FDA483/Warning Letter 6, Initial qualification and routine calibration, maintenance and cleaning...

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Equipment Logs

Equipment Logs

April 15, 2016

An equipment log is the written documentation repository of activity history for a piece of equipment.  This log should detail maintenance work being done, outages, setting changes and other details that may affect the chamber’s operation.  A logbook should not be confused with a laboratory notebook.  The equipment logbook...

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Support Equipment / 483

Support Equipment / 483

April 14, 2016

A potential 483 area to look at is the refrigerators used in the lab.  These units are overlooked when setting up a lab, but not by the inspecting auditors.  These units are used to store samples between the scheduled pull date and the testing time.  Having the support documents...

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Chamber Qualification / 483

Chamber Qualification / 483

April 13, 2016

Related FDA483/Warning Letter 6, Initial qualification and routine calibration, maintenance and cleaning of automatic, mechanical, and electronic. equipment is not performed according to a written program designed to assure proper’ performance www.fda.gov Initial setup of the unit should include a Design Qualification (DQ) to ensure that the unit is...

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Chain of Custody / 483

Chain of Custody / 483

April 12, 2016

Chain of Custody is the documentation of your samples lifecycle history. Most people don’t realize that Chain of Custody starts very early in the manufacturing process and continue through the testing phase. All stages of a sample’s life cycle have some sort of chain of custody or an inventory...

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PSDG Spring 2016 Meeting

PSDG Spring 2016 Meeting

April 11, 2016

We are very pleased and honored to announce that we will be participating PSDG and one of our stability storage process consultants, Gary Ostermiller will give a presentation titled “Human Error and Neglect – 483’s and Warning Letters” at a mini-course on the first day.   PSDG (Pharmaceutical Stability...

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For Attendees of PSDG Spring 2016 Meeting

For Attendees of PSDG Spring 2016 Meeting

April 11, 2016

If you think “This looks like interesting but too busy to check the information.” we support your SOP review and drafting if needed. We will have an “SOP review supporting tour” all over the US in this June, 2016 so please feel free to contact us inquire@naganoscience.com if you are interested in...

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